SUBPART 2Skin Corrosion/Irritation

Definitions

Marginal note:Definitions

skin corrosion means the production of irreversible damage to the skin, namely, visible necrosis through the epidermis and into the dermis, and includes ulcers, bleeding, bloody scabs and, within a 14-day observation period, discoloration due to blanching of the skin, complete areas of alopecia, and scars. (corrosion cutanée)

skin irritation means the production of reversible damage to the skin. (irritation cutanée)

Classification in a Category or Subcategory of the Class

Classification of Substances

Marginal note:Order of provisions

8.2.1 The classification of a skin-corrosive substance or a skin-irritant substance in a category or subcategory of this hazard class must proceed in accordance with the order of sections 8.2.2 to 8.2.7, unless, after applying subsections 8.2.2(1) to (3), the substance is not classified further to subsection 8.2.2(4).

Marginal note:Human data — skin corrosion

8.2.2(1) A substance for which human data demonstrate that it is a skin-corrosive substance is classified in the category “Skin Corrosion — Category 1”.

Marginal note:Animal data — skin corrosion

(2) A substance for which purposely generated animal data demonstrate that it is a skin-corrosive substance is classified in the category “Skin Corrosion — Category 1” and is, if the applicable data are available, further classified in accordance with the following table:

TABLE

Item

Column 1

Column 2

Subcategory

Criteria

1

Skin Corrosion — Category 1A

A substance that, according to animal data acquired from a scientifically validated method, produces irreversible damage to the skin after an exposure of three minutes or less, and within one hour of observation, in at least one of three animals

2

Skin Corrosion — Category 1B

A substance that, according to animal data acquired from a scientifically validated method, produces irreversible damage to the skin after an exposure of more than three minutes and up to and including one hour, and within 14 days of observation, in at least one of three animals

3

Skin Corrosion — Category 1C

A substance that, according to animal data acquired from a scientifically validated method, produces irreversible damage to the skin after an exposure of more than one hour and up to and including four hours, and within 14 days of observation, in at least one of three animals

Marginal note:Human or animal data — skin irritation

(3) A substance for which there are human data or purposely generated animal data with respect to skin irritation is classified in the category “Skin Irritation — Category 2” in accordance with the following table:

(i) in the case of data acquired from a test performed in accordance with the OECD Guideline for the Testing of Chemicals, No. 404, entitled Acute Dermal Irritation/Corrosion, as amended from time to time, a mean score of ≥ 2.3 and ≤ 4.0 for erythema and eschar or for edema in at least two of three animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from gradings on three consecutive days after the onset of skin reactions,

(ii) in the case of data acquired from a scientifically validated method, inflammation, namely, local alopecia, hyperkeratosis, hyperplasia and scaling, that persists to the end of the observation period specified by the method in at least two animals, or

(iii) in the case of data acquired from a scientifically validated method, evidence of severe skin irritation in only one animal

Marginal note:No classification

(4) A substance that meets the following conditions need not be classified in any category or subcategory of this hazard class:

(a) there are human data or purposely generated animal data on the substance, acquired from a scientifically validated method, with respect to skin corrosion or skin irritation;

(b) the substance is not classified further to subsection (1), (2) or (3); and

(c) the data referred to in paragraph (a) demonstrate that it is neither a skin-corrosive substance nor a skin-irritant substance.

Marginal note:Other skin data from animals

8.2.3 A substance for which there are animal data on dermal exposure, acquired from a scientifically validated method, that have not been purposely generated and that demonstrate that the substance is skin-corrosive or skin-irritant is classified, respectively, in the category “Skin Corrosion — Category 1” or the category “Skin Irritation — Category 2”.

Marginal note:In vitro or ex vivo data

8.2.4 A substance for which the data, in vitro or ex vivo, acquired from a scientifically validated method for the evaluation of skin corrosion or skin irritation demonstrate that the substance is skin-corrosive or skin-irritant is classified, respectively, in the category “Skin Corrosion — Category 1” or the category “Skin Irritation — Category 2”.

Marginal note:pH

8.2.5 A substance for which the pH is less than or equal to two or equal to or greater than 11.5 is classified in the category “Skin Corrosion — Category 1”, unless an assessment of alkali or acid reserve performed in accordance with established scientific principles supports the conclusion that it need not be classified as a skin-corrosive substance on the basis of its pH.

Marginal note:Structure-activity relationship — skin corrosion

8.2.6(1) A substance for which a structure-activity relationship, established in accordance with established scientific principles, supports the conclusion that the substance must be classified in the category “Skin Corrosion — Category 1” is classified in that category.

Marginal note:Structure-activity relationship — skin irritation

(2) A substance for which a structure-activity relationship, established in accordance with established scientific principles, supports the conclusion that the substance must be classified in the category “Skin Irritation — Category 2” is classified in that category.

Marginal note:Totality of available data

8.2.7 A substance for which an evaluation of the totality of available data, performed in accordance with established scientific principles, supports the conclusion that the substance is skin-corrosive or skin-irritant is classified, respectively, in the category “Skin Corrosion — Category 1” or the category “Skin Irritation — Category 2”.

Classification of Mixtures

Marginal note:Order of provisions

8.2.8 The classification of a mixture as skin-corrosive or as skin-irritant in a category or subcategory of this hazard class must proceed in accordance with the order of sections 8.2.9 to 8.2.11.

Marginal note:Data available for mixture as a whole

8.2.9(1) If data of the types referred to in subparagraphs 2.1(a)(i) to (iv) are available for the mixture as a whole, the mixture must be classified in accordance with the order of sections 8.2.2 to 8.2.7, unless under subsection 8.2.2(4) the mixture need not be classified.

Marginal note:Data available for mixture as a whole — sections 8.2.10 and 8.2.11

(2) If data of the types referred to in subparagraphs 2.1(a)(i) to (iv) are available for the mixture as a whole, but the mixture cannot be classified further to subsections 8.2.2(1) to (3) or sections 8.2.3 to 8.2.7, its classification in a category or subcategory of this hazard class must proceed in accordance with the order of sections 8.2.10 and 8.2.11.